A Medical Device Daily
LDR (Troyes, France/Austin, Texas), a spine solution company, reported receipt of approval in Japan to market the Easyspine posterior osteosynthesis system in that country.
The Easyspine system was approved by the Ministry of Health, Labor and Welfare in early March, followed by government approval for reimbursement on April 1.
LDR said it had worked closely with the Yufu Itonaga Co. (Tokyo) to obtain the product approval. Yufu Itonaga will distribute and support the Easyspine line in Japan.
Kaoru Sakamoto, president/CEO of Yufu Itonaga, said, "We have been working very diligently and closely with LDR for almost three years to achieve this important milestone. We are proud to be the first in Japan to obtain approval to market a spine system that is delivered sterile to the customer, a very important benefit of the Easyspine system."
Developed in France by LDR Médical with strong surgeon involvement, Easyspine has been used in thousands of procedures to date worldwide. The company said its patent-pending pedicle screw design, with integrated multi-axial capability, provides flat-on-flat screw-to-rod purchase, and can achieve a variety of rigidities by accommodating rods of different thicknesses.
"This design approach provides many technical advantages and creates a system that offers the surgeon increased intra-operative flexibility while only using one-third the inventory levels of conventional fusion systems," LDR said. Additionally, all LDR implant products are delivered to the hospital individually packaged, labeled and sterilized, thereby reducing sterility concerns and improving product traceability - a feature no other spine company currently offers."
Christophe Lavigne, CEO of LDR, said, "The benefit of being able to offer a system that is delivered sterile gives us a strong advantage over other companies. We are very confident that the Yufu Itonaga Co. will be hugely successful in marketing this system in Japan and our organization is ready to dedicate the financial and human resources needed to be successful in this critical market in Asia. This reinforces our strong position in the Asian market and our strategy as an international global spine company."
Cook graft approved in Canada
In what it said is a move reflecting the rapid acceptance of its advanced endograft for thoracic aortic aneurysm worldwide, Cook Medical (Bloomington, Indiana) reported receiving approval to market the Zenith TX2 TAA Endovascular Graft in Canada.
Globally, the Zenith TX2 Endovascular Graft is now available in more than 60 markets, including the U.S., Canada, UK, European Union, Australia and others.
"Physicians around the world have made Cook's Zenith AAA Endograft the world's best-selling device of its kind, and we're now seeing similar momentum in the growing market for endovascular treatment of thoracic aortic aneurysms," said Phil Nowell, global leader of Cook's aortic intervention business unit.
One of Canada's leading endovascular specialists, Cherrie Abraham, MD, of the department of vascular surgery at Jewish General Hospital of McGill University (Montreal), said, "This approval is a recognition that this is an excellent graft that is here to stay. The biggest advantage with TX2 is the control offered by the trifold proximal end. With TX2, we now have the ability to deploy a graft without the wind-sock effect that is seen with other commercially approved thoracic stent grafts. I also like that even after unsheathing the graft, you still have the ability to advance it proximally, again because of the constrained top end."
Cook said U.S. sales of the TX2 Endograft have increased every month since it received FDA clearance in June 2008. During that period, roughly 1,000 physicians at nearly 400 hospitals in the U.S. have requested and received training in the appropriate use of the TX2, making them eligible to bring the advanced benefits of this device to numerous patients suffering thoracic aortic aneurysms.
"With sales of the Zenith TX2 Endograft accelerating each month, and the recent CE-mark approval for our next-generation TX2 Endograft with Pro-Form, we believe Cook is on track to achieve market leadership in thoracic aneurysms, as well," Nowell said
The Zenith TX2 Endograft is indicated in Canada for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.
Products unveiled by Renishaw
Renishaw (Wotton-Under-Edge, UK), is introducing an exciting range of high precision systems for functional and stereotactic neurosurgery at the 15th quadrennial meeting of the World Society for Stereotactic and Functional Neurosurgery taking place in Toronto.
These systems include the neuromate surgical robot, and image-guided stereotactic technologies, some of which are still in development.
To mark the formal introduction of Renishaw's neurosurgical portfolio at the meeting, the company hosted a satellite event. Two leading neurosurgeons discussed their experiences with surgical robotics and other new stereotactic technologies, and their vision for their future use.
Olivier Delalande, MD, pediatric neurosurgeon at the Fondation Rothschild Hospital (Paris), discussed his pioneering use of the neuromate stereotactic robot to perform pediatric procedures including stereo electro-encephalography (SEEG) for epilepsy, and neuroendoscopic disconnection for hypothalamic hamartoma.
Steven Gill, MD, of Frenchay Hospital (Bristol, UK), who is well-known for his pioneering work in placing deep brain stimulation leads, discussed the clinical applications of new technologies in the targeted delivery of therapeutics and their drive towards the requirement for advanced stereotactic systems.
Sir David McMurtry, Renishaw's chairman/CEO, said, "Our commitment to the neurosurgical market is built around listening to the needs of our clinical customers and then delivering advanced precision systems to meet their requirements."
In the year ended June 30, 2008, Renishaw generated revenues of £201.2 million and profit before tax of £41.7 million. The Renishaw Group has more than 50 locations in 31 countries, with some 1,800 employees.